Gongdong
The Gongdong SCR-01Q, SCR-01G and SCR-03G containers provide a receptacle for used, contaminated medical sharps and enclose them during transport to disposal. The filing describes them as…
The Gongdong SCR-01Q, SCR-01G and SCR-03G containers provide a receptacle for used, contaminated medical sharps and enclose them during transport to disposal.
The filing describes them as single-use, disposable, non-sterile containers for healthcare disposal of hazardous sharps such as needles, syringes and lancets.
Listed Item
Sharps Container, 7L, yellow, with Rotor Lid
Container Design
They are made of polypropylene plastic and designed to be puncture-resistant, leak-resistant at the sides and bottom, impact-resistant, closable and stable.
Who Else Makes It
Concentrated in Zhejiang (8), Jiangsu (3), Shanghai (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Yee Hing Foon Plastic Co., Ltd. / Hope Come International | Dongguan | Guangdong | Contract manufacturer | 4 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 18. All 18 manufacturers in China registered for Container, Sharps
Record
| Listed by | Zhejiang Gongdong Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | MMK |
| Device type | Container, Sharps |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K253222 |
| Record published | 2022-08-05 |
| Record revised | 2023-08-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 60, carton of 24, carton of 48, carton of 32, case of 24, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GDC-07-X | In distribution | ||
| 3GAL | In distribution | ||
| SC-05Q | In distribution | ||
| GDC-03-F | In distribution | ||
| GDC-05-X | In distribution | ||
| SC-01G | In distribution | ||
| SCT50 | 24 | In distribution | |
| GDC-13-X | In distribution | ||
| GDC-07-F | In distribution | ||
| SC-06G | In distribution | ||
| 1GAL | In distribution | ||
| GDC-01-F | In distribution | ||
| GDC-05-F | In distribution | ||
| GDC-03-X | In distribution | ||
| SC-02G | In distribution | ||
| SC-02Q | In distribution | ||
| 1QT | In distribution | ||
| SC-01Q | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| APmedical | ABM Italia SPA | 91 |
| Monoject | Cardinal Health | 62 |
| Vermed | Graphic Controls Acquisition Corporation | 52 |
| SharpSafety | Cardinal Health | 37 |
| Mauser Wiva 4 | Envirotain, LLC | 36 |
| Medegen Medical Products | Medegen Medical Products | 32 |
| SharpsTank | Rehrig Pacific Company | 29 |
| Medline | Medline Industries, Inc. | 27 |
| Monoject | Cardinal Health 200, LLC | 24 |
| Daniels | Daniels Corporation International PTY Ltd | 24 |
| Oak Ridge Products | Oakridge Products, LLC | 21 |
| Curaplex | Bound Tree Medical, LLC | 20 |
Showing 12 of 96. All products under Container, Sharps
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253222 | 2025-12-22 |
| K201523 | 2020-11-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.